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Analyses & Displays for Hepatotoxicity

Project Scope:

This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.

Current Status:

  • Finalise Stage 1 white paper following public review.

  • Get Stage 2 white paper ready for public review.

Regular Project Meeting Day/Time:

  • Leads to confirm

Key Skills: (currently being reviewed by WG Leads)

  • Medical background for Stage 2

  • MDs who are experts in DILI assessment

Interactive Analyses and Displays for Laboratory Data – Started Q3 2023

Project Scope:

Interactive Analyses and Displays of laboratory data, applicable to Phase 2-3 clinical trials and integrated submission documents. Creating interactive analyses and displays would allow more options for the user without adding substantial volume and would provide a more user-friendly method for reviewing laboratory data. Multiple groups are involved in creating interactive displays or tools for clinical trial data, and having a deliverable outlining the desired features, with associated education on interpreting the analyses/displays, would help progress the overall efforts.

Current Status:

  • Update to previous PHUSE deliverables, with considerations of interactivity.

Regular Project Meeting Day/Time:

  • Bi-Weekly: Thursday 1517:00-18:00 & 18:00-1619:00 BST

Key Skills: (currently being reviewed by WG Leads)

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